A Clinical Trial to Evaluate Effect of IAE0972 Combined with Chemotherapy for R/M HNSCC or NPC(Note: It is Currently Phase II.).

NCT06719479 | Not Yet Recruiting Phase 2

• 1 other identifier: IAE0972-201
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

Brief Summary

Phase II: To evaluate the safety and tolerability of IAE0972 combined with chemotherapy selected by doctors for R/M HNSCC/NPC after failure or progress of ≤2-line system therapy, and to determine the MTD of combined therapy. Phase III: According to the RECIST 1.1, the effectiveness of IAE0972 combined with chemotherapy regimen chosen by doctors compared with placebo plus chemotherapy regimen chosen by doctors was evaluated through OS in patients with R/M NPC who failed or progressed after treatment with ≤2-line system.

Conditions

NPC; HNSCC; Recurrence; Metastasis

Keywords

NPC; HNSCC; Recurrence; Metastasis

Outcome Measures

Primary Outcomes (1)

• Number of participants with treatment-related adverse events assessed by CTCAE v5.0.

  AE was defined as any untoward medical occurrence in a participant administered a study treatment and which does not necessarily have to have a causal relationship with this treatment. An AE could therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the study treatment or protocol-specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a pre-existing condition that was temporally associated with the use of study treatment, was also an AE. The number of participants who experienced at least one AE is presented.

  up to 2 years

Secondary Outcomes (4)

• Overall survival (OS)

  up to 2 years

• Objective response rate (ORR)

  up to 2 years

• Disease control rate (DCR)

  up to 2 years

• Progression-free survival (PFS)

  up to 2 years

Study Arms (5)

Cohort 1

EXPERIMENTAL

In Phase II，the patients will receive the combined treatment of IAE0972（7.5 mg/kg、10 mg/kg、15 mg/kg、20 mg/kg）+ Methotrexate（Chemotherapy chosen by doctors）. Every 21 days is defined as a treatment cycle.

Biological: IAE0972+ Methotrexate

Cohort 2

EXPERIMENTAL

In Phase II，the patients will receive the combined treatment of IAE0972（7.5 mg/kg、10 mg/kg、15 mg/kg、20 mg/kg）+ Docetaxel（Chemotherapy chosen by doctors）. Every 21 days is defined as a treatment cycle.

Biological: IAE0972+Docetaxel

Cohort 3

EXPERIMENTAL

In Phase II，the patients will receive the combined treatment of IAE0972（7.5 mg/kg、10 mg/kg、15 mg/kg、20 mg/kg）+ Gemcitabine（Chemotherapy chosen by doctors）. Every 21 days is defined as a treatment cycle.

Biological: IAE0972+Gemcitabine

Cohort 4

EXPERIMENTAL

In Phase II，the patients will receive the combined treatment of IAE0972（7.5 mg/kg、10 mg/kg、15 mg/kg、20 mg/kg）+ Taxanes （Chemotherapy chosen by doctors）. Every 21 days is defined as a treatment cycle.

Biological: IAE0972+Taxanes

Cohort 5

EXPERIMENTAL

In Phase II，the patients will receive the combined treatment of IAE0972（7.5 mg/kg、10 mg/kg、15 mg/kg、20 mg/kg）+ Capecitabine（Chemotherapy chosen by doctors）. Every 21 days is defined as a treatment cycle.

Biological: IAE0972+Capecitabine

Interventions

IAE0972+ Methotrexate BIOLOGICAL

IAE0972: every 21 days is defined as a treatment cycle, and IAE0972 is infused intravenously on the 1d, 8d and 15d of each cycle. The first infusion time is about 120 min (which can be adjusted according to the actual situation); If the subjects are well tolerated when they receive the study drug for the first time (according to CTCAE 5.0, the infusion-related reaction is ≤ grade 1), the follow-up infusion time can be 60\~90 min (which can be adjusted according to the actual situation).Methotrexate is used according to the instructions.

Cohort 1

IAE0972+Docetaxel BIOLOGICAL

IAE0972: every 21 days is defined as a treatment cycle, and IAE0972 is infused intravenously on the 1d, 8d and 15d of each cycle. The first infusion time is about 120 min (which can be adjusted according to the actual situation); If the subjects are well tolerated when they receive the study drug for the first time (according to CTCAE 5.0, the infusion-related reaction is ≤ grade 1), the follow-up infusion time can be 60\~90 min (which can be adjusted according to the actual situation).Docetaxel is used according to the instructions.

Cohort 2

IAE0972+Gemcitabine BIOLOGICAL

IAE0972: every 21 days is defined as a treatment cycle, and IAE0972 is infused intravenously on the 1d, 8d and 15d of each cycle. The first infusion time is about 120 min (which can be adjusted according to the actual situation); If the subjects are well tolerated when they receive the study drug for the first time (according to CTCAE 5.0, the infusion-related reaction is ≤ grade 1), the follow-up infusion time can be 60\~90 min (which can be adjusted according to the actual situation).Gemcitabine is used according to the instructions.

Cohort 3

IAE0972+Taxanes BIOLOGICAL

IAE0972: every 21 days is defined as a treatment cycle, and IAE0972 is infused intravenously on the 1d, 8d and 15d of each cycle. The first infusion time is about 120 min (which can be adjusted according to the actual situation); If the subjects are well tolerated when they receive the study drug for the first time (according to CTCAE 5.0, the infusion-related reaction is ≤ grade 1), the follow-up infusion time can be 60\~90 min (which can be adjusted according to the actual situation).Taxanes is used according to the instructions.

Cohort 4

IAE0972+Capecitabine BIOLOGICAL

IAE0972: every 21 days is defined as a treatment cycle, and IAE0972 is infused intravenously on the 1d, 8d and 15d of each cycle. The first infusion time is about 120 min (which can be adjusted according to the actual situation); If the subjects are well tolerated when they receive the study drug for the first time (according to CTCAE 5.0, the infusion-related reaction is ≤ grade 1), the follow-up infusion time can be 60\~90 min (which can be adjusted according to the actual situation).Capecitabine is used according to the instructions.

Cohort 5

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• The age is 18\~75 years old (including the critical value), regardless of gender.
• Phase II cohort 1, cohort 2: locally advanced squamous cell carcinoma of the head and neck which only occurred in the oral cavity, oropharynx, hypopharynx and larynx after histological diagnosis or had no indication of radical local treatment; In the past, I only received ≤2 line therapy for recurrent and metastatic head and neck squamous cell carcinoma.
• Phase II cohort 3, cohort 4, cohort 5: Histologically confirmed nasopharyngeal carcinoma, stage IVb or recurrent nasopharyngeal carcinoma that is not suitable for local treatment according to the TNM of AJCC nasopharyngeal carcinoma in the 8th edition of 2017; In the past, they only received ≤2 line therapy for recurrent and metastatic nasopharyngeal carcinoma.
• According to the researcher's judgment, the chemotherapy in this experiment is applicable.
• According to the RECIST 1.1 standard, there is at least one measurable lesion (tumor lesions located in previous radiotherapy areas or other local regional treatment sites are generally not regarded as measurable lesions, unless the lesions make clear progress or persist after radiotherapy for three months).
• The score of physical condition of the ECOG is 0\~1.
• The estimated survival time is ≥3 months.
• Have sufficient organ functions:
• Blood system (no blood transfusion or hematopoietic stimulating factor treatment within 14 days): ANC≥1.5×109/L, PLT≥90×109/L, HGB≥ 90 g/L; ② Liver function: TBIL≤1.5 times the ULN, except Gilbert syndrome; AST and ALT are ≤3.0 times ULN, while subjects with liver metastasis or liver cancer need AST and ALT≤3.0 times ULN and total bilirubin ≤ 3.0 times ULN;
• Renal function: Cr≤1.5 times ULN; If the creatinine is more than 1.5 times ULN, the CCR should be ≥ 50 ml/min (calculated according to Cockcroft-Gault formula);
• Coagulation function: INR≤1.5 times ULN, APTT≤1.5 times ULN, and INR and APTT≤2.5 times ULN for patients with liver metastasis or liver cancer.
• Qualified fertile subjects (male and female) must agree to use reliable contraceptive methods (hormone or barrier method or abstinence) with their partners during the trial and at least 6 months after the last medication; The blood pregnancy test of female subjects of childbearing age must be negative within 7 days before the first use of the study drug.
• Subjects must give informed consent to this study before the experiment, and voluntarily sign a written informed consent form.

You may not qualify if:

• Having received chemotherapy, radiotherapy, biotherapy, endocrine therapy, immunotherapy and other anti-tumor treatments within 4 weeks before the first use of the investigating drug, the following drugs should be excluded according to the following criteria:
• ① Nitrosourea or mitomycin C was used within 6 weeks before the first use of the study drug;
• ② Oral administration of fluorouracil and small molecule targeted drugs 2 weeks before the first use of the study drug or within 5 half-lives of the drug (whichever is longer);
• ③ Chinese patent drugs with anti-tumor indications were used within 2 weeks before the first use of the study drugs.
• Received other unlisted clinical research drugs or treatments within 4 weeks before using the research drugs.
• The adverse reactions of previous anti-tumor treatments have not recovered to NCI CTCAE 5.0 grade evaluation ≤1 grade or the relevant provisions of the selection criteria (except for the toxicity that the researchers judged to have no safety risk, such as alopecia, grade 2 peripheral neurotoxicity, hypothyroidism stabilized by hormone replacement therapy, etc.).
• It is known that it has hypersensitivity to any antibody drugs (NCI CTCAE 5.0 rating is ≥3), or it has hypersensitivity to research drugs, active ingredients or inactive excipients of chemotherapy schemes.
• Have received major surgery (excluding puncture biopsy), major trauma or need to undergo elective surgery during the trial within 4 weeks before the first use of the study drug.
• Having received systemic corticosteroids (prednisone \> 10 mg/day or similar drugs with the same dose) within 14 days before the first use of the study drug, except for the following cases: using topical, ophthalmic, intra-articular and intranasal corticosteroids; Short-term use of glucocorticoids for preventive treatment (for example, prevention of contrast agent allergy).
• Treatment with other immunosuppressants within 28 days or 5 half-lives (whichever is longer) before the first use of the study drug.
• Have used immunomodulatory drugs within 14 days before the first use of the study drug (Appendix 5).
• Have been vaccinated with any live vaccine within 4 weeks before the first use of the study drug.
• Received allogeneic hematopoietic stem cell transplantation or organ transplantation in the past.
• Brain parenchymal metastasis or meningeal metastasis with clinical symptoms.
• It has active infection and needs intravenous anti-infection treatment at present.

Sponsors & Collaborators

• SUNHO（China）BioPharmaceutical CO., Ltd.: lead

MeSH Terms

Conditions

Squamous Cell Carcinoma of Head and Neck; Recurrence; Neoplasm Metastasis

Condition Hierarchy (Ancestors)

Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Head and Neck Neoplasms; Neoplasms by Site; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Neoplastic Processes

Central Study Contacts

Hai Qiang Mai, Ph.D

CONTACT

86-20-87343643; maihq@sysucc.org.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 27, 2024
• First Posted: December 5, 2024
• Study Start: January 1, 2025
• Primary Completion (Estimated): January 1, 2028
• Study Completion (Estimated): January 1, 2028
• Last Updated: December 5, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share